Breast cancer is the most frequently diagnosed cancer in women, with an estimated 212,920 new cases of invasive breast cancer expected in the United States in 2006. Over one-half of these women will have estrogen receptor positive, lymph node negative breast cancer. For 80 percent to 85 percent of those women, the current standard treatment practice is surgical excision of the tumor, followed by radiation and hormonal therapy. Chemotherapy is also recommended for most women, but the proportion of women who actually benefit substantially from chemotherapy is fairly small.
A large number of these women are receiving toxic chemotherapy unnecessarily, and we need a means of identifying them, said Jo Anne Zujeweski, M.D., senior investigator in the Clinical Investigation Branch of NCIs Cancer Therapy Evaluation Program. TAILORx could help change the way we treat breast cancer and improve the quality of patients lives, helping to better identify women who are likely to benefit from chemotherapy from those who are not.
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Oncotype DX measures the levels of expression of 21 genes (whether they are transcribed into messenger RNA) in breast tumors. This assessment can more precisely estimate a persons risk of recurrence than standard characteristics, such as tumor size and grade. Based on the Oncotype DX gene expression analysis, a recurrence score from 0 to 100 is generated; the higher the score, the greater a womans chance of having a recurrence if treated with hormonal therapy alone.
Women will be studied for 10 years, with an additional follow-up of up to 20 years after initial therapies. Based on their recurrence score, women will be assigned to three different treatment groups in the TAILORx study:
* Women with a recurrence score higher than 25 will receive chemotherapy plus hormonal therapy (the standard of care)
* Women with a recurrence score lower than 11 will receive hormonal therapy alone
* Women with a recurrence score of 11 to 25 will be randomly assigned to receive adjuvant hormonal therapy, with or without chemotherapy.
TAILORx is designed primarily to evaluate the effect of chemotherapy on those with a recurrence score of 11 to 25. Women in this last group will comprise 4,390 women, or about 44 percent of the study population. Because the degree of benefit of chemotherapy for women with recurrence scores between 11 and 25 is uncertain, TAILORx seeks to determine if the Oncotype DX test will be helpful in future treatment planning for this group.
